Upper Respiratory Tract InfectionsNCT01215682
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
A study testing vitamin D in people with Upper Respiratory Tract Infections, run by Sheba Medical Center at 4 sites in Israel.
Trial summary
Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 4 sitesIsrael
- Study dates
- Oct 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- members of swimming team
- training at least 15 hours/week
- low vitamin D plasma levels (<30 ng/ml)
- signed consent forms
Who cannot join
- chronic health conditions
- taking prescription medications
- taking diet supplementations
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Maccabi Haifa Swimming Club
Haifa
Bnei Herzlyia Swimming Club
Herzlyia
Hod Hasharon Swimming Club
Hod HaSharon
Maccabim-Reut Swimming Club
Maccabim
About this study
Official title: Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field.
The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function.
Read more
Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed.
Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- vitamin D, placebo
- Keywords
- infections, immune system, vitamin D, sport, children
- Medical subject headings
- Respiratory Tract Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
2000 IU/day of vitamin D3 as a once-daily dose
placeboDietary supplement
sweetened water
| Study group | Role | What they receive |
|---|---|---|
| vit D | Active comparator | Not described Receives: Dietary Supplement: vitamin D |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
URI frequency
URI frequency will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
Measured: 3 months
URI duration
URI duration will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
Measured: 3 months
UTI severity
URI severity will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
Measured: 3 months
Secondary outcomes (3)
plasma vitamin D levels
Measured: 3 months
immune system function
T-cell receptor excision circles (TREC), T cell receptor repertoire, B-cell receptor excision circles (BREC). Comparison will be made with changes in vitamin D levels and with URI characteristics.
Measured: 3 months
physical function
absence from school or training, land and swimming fitness tests. Comparison will be made with changes in vitamin D levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gal Raz-Dubnov MD, MSc, Sheba Medical Center
- Investigators
- Gal Dubnov-Raz, MD MSc, Principal investigator, Sheba Medical CenterNaama W Constantini, MD, Principal investigator, Hadassah Medical OrganziationAvner Cohen, MD, Principal investigator, Clalit Health ServicesRaz Somech, MD PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215682
- Sponsor's protocol ID
- SHEBA-10-7762-GDR-CTIL
- Status last verified
- Mar 2012
- First submitted
- 5 Oct 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dubnov-Raz G, Rinat B, Hemila H, Choleva L, Cohen AH, Constantini NW. Vitamin D supplementation and upper respiratory tract infections in adolescent swimmers: a randomized controlled trial. Pediatr Exerc Sci. 2015 Feb;27(1):113-9. doi: 10.1123/pes.2014-0030. Epub 2014 Jul 15.
PubMed 25050610
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
- ClinicalTrials.gov ID
- NCT01215682
- Acronym / sponsor ID
- SHEBA-10-7762-GDR-CTIL
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- infections, immune system, vitamin D, sport, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field.
The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function.
Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed.
Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vit D | Active comparator | Dietary Supplement: vitamin D |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- members of swimming team
- training at least 15 hours/week
- low vitamin D plasma levels (<30 ng/ml)
- signed consent forms
Key exclusion criteria (3 listed)
- chronic health conditions
- taking prescription medications
- taking diet supplementations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D2000 IU/day of vitamin D3 as a once-daily dose | Dietary supplement | vit D |
| placebosweetened water | Dietary supplement | placebo |
Primary outcome
URI frequency
Time frame: 3 months
URI frequency will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
URI duration
Time frame: 3 months
URI duration will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
UTI severity
Time frame: 3 months
URI severity will be measured in both groups, starting 4 weeks after initiating the suplementation. Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
3 secondary outcomes
plasma vitamin D levels
Time frame: 3 months
immune system function
Time frame: 3 months
physical function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 25050610Dubnov-Raz G, Rinat B, Hemila H, Choleva L, Cohen AH, Constantini NW. Vitamin D supplementation and upper respiratory tract infections in adolescent swimmers: a randomized controlled trial. Pediatr Exerc Sci. 2015 Feb;27(1):113-9. doi: 10.1123/pes.2014-0030. Epub 2014 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Dubnov-Raz, MD MSc principal investigator
Sheba Medical Center
Naama W Constantini, MD principal investigator
Hadassah Medical Organziation
Avner Cohen, MD principal investigator
Clalit Health Services
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Upper Respiratory Tract Infections, run by Sheba Medical Center at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
URI frequency (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.